Phase 2 Bladder Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older at the time of giving consent.
• People who are willing and able to follow the study schedule, attend all appointments, and sign a written consent form.
• People whose general health and ability to carry out daily activities meets a specific standard (called ECOG score of 0 or 1), assessed within 28 days before joining.
• People who have been diagnosed with non-muscle-invasive bladder cancer (cancer that has not grown into the main muscle wall of the bladder) — either with carcinoma in situ (a flat, high-grade lesion) with or without high-grade papillary tumours (Cohort A), or with high-grade papillary tumours only (Cohort B) — assessed three months after completing an initial course of BCG treatment.
• People whose bladder cancer is of mixed cell type (such as a mix of regular bladder cancer with adenocarcinoma or squamous cell carcinoma) — pure variant histology is not eligible (confirm with trial site).
• People whose cancer either did not respond to BCG treatment or came back after BCG treatment, meeting specific definitions for "BCG-unresponsive" or "BCG-exposed" disease (confirm with trial site for exact definitions).
• People who have received up to two previous treatment courses for non-muscle-invasive bladder cancer (not including PD-1 or PD-L1 immunotherapy, which is not permitted).
• People who have been assessed by their treating doctor as not suitable for bladder removal surgery, or who have declined that surgery, with the reason documented in their medical record.
• People who have had all visible tumours completely removed within 60 days before joining (residual carcinoma in situ is permitted).
• People who have had a bladder examination (cystoscopy or TURBT) showing no papillary tumours and a negative urine test within 28 days before joining (a positive urine test is allowed for those with carcinoma in situ only).
• People with T1 tumours who have undergone a second, re-staging surgical procedure (TURBT) within 60 days before joining, with muscle tissue confirmed in the sample.
• People who have tumour tissue samples available from a previous procedure, with a minimum of 2 and up to 10 tissue slides available for research purposes — those without available tissue are not eligible.
• People whose blood counts and organ function (including blood cells, liver, kidneys, and clotting) meet specific levels measured within 28 days before joining (confirm with trial site for exact values).
• Women who could become pregnant must have a negative pregnancy test within 7 days before joining and must agree to use contraception throughout the study.
• Men who could father a child must agree to use contraception throughout the study.
• People who have a life expectancy of at least 12 weeks.

Who may not be able to join:

• People who have previously received immunotherapy drugs that target PD-1, PD-L1, PD-L2, CTLA-4, OX-40, CD137, or similar immune checkpoint pathways.
• People who have had carcinoma in situ in the ureters or the part of the urethra running through the prostate within the past 24 months.
• People who have evidence of cancer that has spread to other parts of the body, based on CT or MRI scans of the abdomen and pelvis taken within 90 days before joining.
• People who weigh 30 kg or less.
• People who have had an organ transplant from another person.
• People who have had another cancer diagnosis within the past 5 years, with some exceptions for cancers that were treated with the intention of cure and have shown no signs of return, or cancers considered very low risk (confirm with trial site for specific exceptions).
• People who are currently taking part in, or have taken part in, another clinical trial of an experimental treatment within 4 weeks before the first dose, or within 5 half-lives of the previous experimental drug — whichever is longer — and have not recovered from significant side effects of that treatment.
• People who have an active or previous autoimmune or inflammatory condition that required systemic medical treatment within the past 24 months (such as lupus, rheumatoid arthritis, inflammatory bowel disease, or multiple sclerosis, among others), with some exceptions (confirm with trial site).
• People who have a diagnosis of immune deficiency, or who are taking regular steroid medication at doses above 10 mg per day of prednisone (or equivalent), or other immune-suppressing medications within 7 days before joining — with exceptions for hormone replacement therapy.
• People who have a known psychiatric condition or substance use disorder that would make it difficult to follow the study requirements.
• People with active tuberculosis.
• People who have had symptoms of shingles (herpes zoster) within the past 30 days.
• People who have an active infection that requires treatment with systemic medication (antibiotics taken by mouth or through a drip) — with some exceptions (confirm with trial site).
• People who have a history of idiopathic pulmonary fibrosis or organising pneumonia (specific types of lung scarring conditions).
• People who have a history of non-infectious lung inflammation that required steroid treatment, or who currently have lung inflammation.
• People living with HIV may be eligible only if they are on effective HIV treatment with an undetectable viral load within 6 months of joining, and do not have a history of Kaposi sarcoma or Multicentric Castleman Disease.
• People with active hepatitis B or C infection, or certain positive hepatitis test results, may not be eligible — with some exceptions for past resolved infections (confirm with trial site).
• People with a known co-infection of hepatitis B and C, or hepatitis B and D.
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have received a live vaccine (such as measles, mumps, chickenpox, or BCG) within 30 days before starting treatment — COVID-19 vaccines are permitted, and injected seasonal flu vaccines are generally allowed.
• People who have had a major surgical procedure within 28 days before the first dose of study treatment.
• People with serious uncontrolled health conditions, including uncontrolled heart failure, uncontrolled high blood pressure, unstable chest pain, irregular heart rhythms, interstitial lung disease, serious ongoing bowel conditions with diarrhoea, or mental health or social situations that would affect their ability to participate safely.
• People with a specific heart rhythm measurement (QTcF) of 470 milliseconds or more, based on three ECG readings.
• Women who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception.
• People who still have unresolved side effects of grade 2 or higher from previous cancer treatments (with some exceptions such as hair loss or certain stable lab values — confirm with trial site).
• People who are currently receiving any other chemotherapy, biological therapy, or hormonal cancer treatment — hormonal therapy for non-cancer reasons is permitted.
• People who have a history of cancer spreading to the membranes surrounding the brain and spinal cord (leptomeningeal carcinomatosis).
• People who have previously taken part in a clinical trial involving durvalumab (the study drug), regardless of which treatment group they were in.
• People who have used immune-suppressing medication within 14 days before the first dose of durvalumab — with exceptions for low-dose inhaled, topical, or local steroids, low-dose systemic steroids, and steroids used to prevent allergic reactions to scans or procedures.

Important: Always verify eligibility with the trial site directly before applying.